Professional Documents
Culture Documents
: 200043138
TEST REPORT
MEDICAL ELECTRICAL EQUIPMENT
Equipment / Product LCD type Computer
Name and address of the applicant Advantech Co., Ltd.
4F, No. 108-3, Ming-Chuan Road.
Shing-Tien City, Taipei
TAIWAN, R.O.C.
Name and address of the Advantech Co., Ltd.
manufacturer 4F, No. 108-3, Ming-Chuan Road.,
Shing-Tien City, Taipei
TAIWAN, R.O.C.
Name and address of the factory Advantech Co., Ltd.
Fl. 7, NO. 1, Lane 169, Kang-Ning Street
Xi-Zhi Town, Taipei Hsien
TAIWAN, R.O.C.
Trade mark ADVANTECH
Model/type PPC-xxyM (Explanation for xxy on page 3 in this report)
Rating and principal 100-250Vac, 3A, 50/60Hz, Class I equipment
characteristics
Serial no
Test sample(s) received, date 24. oct. - 2000
Tested in the period, dates Oct. -Nov. - 2000
Tested according to IEC 60601-1 (2 ed 1988) + Amend. 1 (1991) + Amend. 2 (1995)
+ Corrigendum (June 1995)
MEDICAL ELECTRICAL EQUIPMENT - Part 1: General requirements for safety
Result of testing The equipment complies with the above mentioned standards.
The test results relate only to the sample(s) tested.
Name and address of the testing Telephone
laboratory (+47) 22 96 03 30
P.O. BOX 73 BLINDERN, Fax
N - 0314 OSLO, NORWAY (+47) 22 96 05 50
Tested by
Signature date
Johny Giang
Verified by
Signature date
Frank Skarpsno
Nemko AS
Verdicts are placed in the column to the right.: P = Pass, F = Fail, N = Not applicable, = Considered/Information.
Due to Nemkos computerised handling of test reports the layout of this form is modified compared to the original TRF published by EMEDCA; 1992-12-01.
The content fully covers the original TRF.
This form is only for use by Nemko, or by others according to special agreement with Nemko. The completed test report is not valid for external use, unless
issued by Nemko or attached to a Nemko certification document. The report shall not be reproduced without written permission from Nemko and may then only
be copied in full.
Issue Nemko 97-09-05
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SUMMARY OF TESTING
Evaluation of Results
If not explicitly stated otherwise in the standard, the test is passed if the measurement value is equal to or below the limit line,
regardless of the uncertainty of the measurement. If the measurement value is above the limit line, the test is not passed - ref.
IEC 60EE/CTL (sec) 056/94 (CLT = Committee of Testing Laboratories).
The instrument accuracy is within limits agreed by this committee (ref. Nemko proc P227):
Models PPC-xxyM
where xx can be 12 or 15 for 12 LCD or 15 LCD
where y can be 0-9
This computer uses adaptor (Skynet, Model SNP -8086-M which has CB)
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3 GENERAL REQUIREMENTS
3.1 EQUIPMENT when transported, The equipment causes no hazards when used according P
stored, installed, operated in NORMAL the manufacturers instructions.
USE and maintained according to the
instructions of the manufacturer, causes
no SAFETY HAZARD which could
reasonably be fore- seen and which is
not connected with its intended
application in NORMAL CONDITION
and in S.F.C.
3.4 An alternative means of construction is No alternative construction. N
used to that detailed in this standard
and it can be demonstrated that an
equivalent degree of safety is obtained.
5 CLASSIFICATION
5.1 Type of protection against electric Class I equipment.
shock.
5.2 Degree of protection against electric No applied part. This is a Personal Computer. As the
shock. equipment is not intended to be connected to the patient
and does not have any patient applied parts, it is not
marked with the type B applied part symbol.
5.3 Classification of the equipment against Ordinary equipment.
ingress of liquids.
5.5 Degree of safety of application in the The equipment is not an AP or APG category
presence of a FLAMMABLE equipment.
ANAESTHETIC MIXTURE WITH
AIR or WITH OXYGEN OR
NITROUS OXIDE
5.6 Mode of operation. Continuous operation.
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INSULATION DIAGRAM
Protection against electric shock - Refer to table on next page. P
Block diagram of system
Drawing
A-a2
Prim. Sec.
A-f
A-e
A-k
B-a
Comments
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Comments
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6.1 b Markings of Internally Powered Not applicable. Not internally powered equipment N
EQUIPMENT
6.1 c Markings of EQUIPMENT supplied Not applicable. N
from a specified power supply
6.1 d Minimum requirements if limited space Not applicable. N
for marking
6.1 e Name and/or trademark of the See front page P
manufacturer or supplier
6.1 f Model or type reference See front page P
6.1 g Rated supply voltage(s) or voltage 100-250 V Single phase a.c. P
range(s)
Number of phases
Type of current 3A
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6.2 d Type of battery and mode of insertion Back up battery. Type M4T28-BR12SH1, P
(if applicable) marked (see Sub-clause rating 5V, 50mAh
56.7 b)
Batteries not intended be changed by P
operator and which can be changed
only with use of tool have at least
marking referring to information in
accompanying documents
6.2 e Fuse type and rating or reference stated GBP, 12A, 250Vac P
6.2 f P
Protective earth terminal marked
6.2 g Functional earth terminal marked Not applicable. N
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6.8 Accompanying documents
6.8.1 Equipment is accompanied at least by
- instructions for use User Manual P
- technical description User Manual P
- an address to which the user can refer User Manual P
All applicable classifications specified User Manual P
in Clause 5 are included in instructions
for use and technical description
markings in Sub-clause 6.1 included in P
accompanying documents if not
permanently affixed to equipment
Warning statements and explanations Not used N
of warning symbols are provided in
accompanying documents
Language of accompanying documents English. Will be in the language required for the market P
where the equipment is intended to be sold.
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7 POWER INPUT
7.1 Steady state current or power input Input power: 100-250Vac, 3A, 50/60Hz P
does not exceed the marked rating by
Deviation: (measured-rated)*100/rated = %
more than specified
Equipment: N3635
Initials Tester / Date: JohnyG / 10-2000
Power input Function UNlower = 90 V UN = 170 V UN upper = 275V
Input current Normal operation (A) 1,4/1,4 0,98/0,98 0,6/0,6
Standby (A)
Input power Normal operation (W) 69/69 68/67 68/68
Input power Normal operation (VA)
Power factor cos 0,54/0,54 0,48/0,47 0,40/0,41
Comments Power input rated is measured at both 50 and 60Hz. The 50Hz values are showed before /
and the 60Hz is back. (Remark: #PPC-15yM-zT)
10 ENVIRONMENTAL CONDITIONS
10.1 Equipment capable, while packed for Considered OK. P
transport and storage, of being exposed
to environmental conditions as stated
by manufacturer (see 6.8.3 d)
10.2 Operation of equipment according to Considered OK. P
specified environment and power
supply
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13 GENERAL
Equipment so designed that risk of Considered OK. P
electric shock obviated as far as
practicable (requirements as given in
section three)
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17 SEPARATION
17 a Separation method of the applied part No applied part
from live parts so that allowable
leakage currents are not exceeded
17 a 1 Basic insulation - applied part earthed N
17 a 2 By protectively earthed conductive part N
(e.g. screen)
17 a 3 By separate earthed intermediate circuit N
17 a 4 By double or reinforced insulation N
17 a 5 By protective impedances limiting . N
current to applied part
17 a 6 Other method, e.g. specified in N
particular standard
Equipment:
Initials Tester / Date:
Additional leakage current test in single fault conditions
Fault condition Earth leakage current Enclosure leakage Patient leakage Patient auxiliary
(description) current current current
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A-j
A-k 250 V AC 4 000 V AC OK
Equipment B-a 250 V AC 4 000 V AC OK
types with B-b
applied part B-c
B-d
B-e
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A-j
A-k 250 V AC 4 000 V AC OK
Equipment B-a 250 V AC 4 000 V AC OK
types with B-b
applied part B-c
B-d
B-e
21 MECHANICAL STRENGTH
21 a Rigidity of enclosure (45 N test force) Tested with 45 N. No damage to enclosure parts. P
21 b Strength of enclosure part and any No damage resulting in a safety hazard. P
component thereon (Impact hammer
test, 0.5 J).
21 c On portable equipment carrying No handles or grips used N
handles or grips withstand the
requirements of the loading test. (Test
force four times the weight of
equipment)
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22 MOVING PARTS
22.2 a Moving parts of transportable No moving parts used N
equipment are provided with guards
which form an integral part of the
equipment
22.2 b Moving parts of stationary equipment N
are provided with similar guards as
above unless it is evident that
equivalent protection is separately
provided during installation
22.3 Cords (ropes), chains and bands are N
confined so they cannot run off or jump
out of their guiding devices
Other means used to prevent a safety N
hazard
Mechanical safeguard means are N
removable only with a tool
22.4 Dangerous movements of equipment N
parts, which may cause physical injury
to the patient, are possible only by the
continuous activation of the control
22.6 Parts of equipment subject to N
mechanical wear are accessible for
inspection
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25 EXPELLED PARTS
25.1 Protective means are provided where Not applicable. N
expelled parts of the equipment could
constitute a safety hazard
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28 SUSPENDED MASSES
28.3 Suspension systems with safety No suspended masses N
devices:
Suspension systems include a safety N
device with adequate safety factors to
protect user or patient from hazards
If after activation of a safety device the N
equipment can still be used, the
activation of the device, e.g. a
secondary rope, becomes obvious to
the operator
28.4 Suspension systems of metal without N
safety devices:
The construction of the suspension N
complies with:
28.4 1 The TOTAL LOAD does not exceed N
the SAFE WORKING LOAD
28.4 2 Where it is unlikely that supporting N
characteristics will be impaired by
wear, corrosion, material fatigue or
ageing, the SAFETY FACTOR of all
supporting parts is not less than 4
28.4 3 Where impairment by wear, corrosion, N
material fatigue is expected, the
SAFETY FACTOR is not less than 8
28.4 4 Where metal having a specific N
elongation at break of less than 5% is
used in supporting components, the
SAFETY FACTOR is not less than 1.5
times those given in 2) and 3) above
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29 X-RADIATION
29.1 Diagnostic X-ray equipment, see IEC No X-radiation N
601-1-3. Radiotherapy equipment, see
relevant Particular standard
29.2 For equipment not intended to produce N
X-radiation for diagnostic and
therapeutic purposes, ionising radiation
emitted by vacuum tubes excited by
voltages exceeding 5 kV does not
produce an exposure exceeding 130
nC/kg (0.5 mR)
31 MICROWAVE RADIATION
No general requirement.
33 INFRA-RED RADIATION
No general requirement.
34 ULTRAVIOLET RADIATION
No general requirement.
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36 ELECTROMAGNETIC COMPATIBILITY
IEC 60601-1-2 ( 1993 ) Compliance documented by the manufacturer. P
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42 EXCESSIVE TEMPERATURES
Ambient temperature during See tables below.
measurements:
Humidity: 40%rh
Atmospheric pressure: 995hPa
Equipment: Humidity : N2531
Pressure : N2842
Initials Tester / Date: JohnyG / 11-2000
42.1 - 42.2 Determination of the temperature with P
thermocouples:
Equipment: N3008, N3635, N2859, N3132
Initials Tester / Date: JohnyG / 11-2000
Quantity Rated Used in tests Remarks
Supply voltage, V 100-250V AC 90, 275 V AC
Supply power, VA
Output power, VA
Measuring point Measured Calculated Measured Calculated Allowed Remarks
temp. temp. temp. temp. max.
t (K) T (C) t (K) T (C) temp. T
(C)
A: IP 90Vac, 60Hz A B
B: IP 275Vac, 60Hz
1. Ambient, T = 25 C
2. T1 coil 40 80 43 68 Cl.B Table Xa
130C
3. T1 core 36 76 39 64 Table Xa
4. L1 coil 35 60 30 55 Table Xb
5. BT1 body 26 51 26 51 Table Xb
6. V1 body 30 55 31 56 Table Xb
7. L6 coil 29 54 29 54 Table Xb
8. T1 coil for inverter 65 105 65 105 Cl.B Table Xa
130C
9. T1 core for inverter 70 110 70 110 Table Xa
10. F1 coil for inverter 58 83 58 83 Table Xb
11. Surface of PC 13 53 13 53 75 Table Xa
12. SMP for building-in:
Skynet SNP-8086-M. See
Nemko ref. 200039133
Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise for
determination of the final temperature T.
Model PPC-150M-zT
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A: IP 90Vac, 60Hz A B
B: IP 275Vac, 60Hz
1. Ambient, T = 25 C
2. L1 coil 60 85 50 75 Table Xb
3. BD1 body 69 94 57 83 Table Xb
4. C8 body 46 71 42 67 Table Xb
5. T1 coil 70 110 76 116 Cl.B Table Xa
6. T1 core 67 107 73 113 Table Xa
7. L4 coil 76 101 79 104 Table Xb
8. L3 coil 61 86 63 88 Table Xb
9. HS body of Q1 41 66 42 67 Table Xb
10. V36 body 29 54 29 54 Table Xb
11.cpu body 37 62 36 61 Table Xb
12.H.DD body 25 50 25 50 Table Xb
13. F.DD body 19 44 19 44 Table Xb
14. CD rom body 27 52 27 52 Table Xb
15. V1 body 29 54 29 54 Table Xb
16. L48 body 26 51 26 51 Table Xb
17. T1 coil for inverter 62 102 62 102 Cl.B Table Xa
18. T1 core for inverter 48 88 48 88 Table Xa
19. L1 coil for inverter 56 81 56 81 Table Xb
20. Surface of PC 13 53 13 53 75 Table Xa
12. SMP for building-in:
Skynet SNP-8086-M. See
Nemko ref. 200039133
Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise for
determination of the final temperature T.
Model PPC-120M-zT
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A: IP 90Vac, 60Hz A B
B: IP 275Vac, 60Hz
1. Ambient, T = 25 C
2. L1 coil 52 77 43 68 Table Xb
3. BD1 body 65 90 50 75 Table Xb
4. C8 body 40 65 34 59 Table Xb
5. T1 coil 70 110 71 111 Cl.B Table Xa
6. T1 core 62 102 66 106 Cl.B Table Xa
7. L4 coil 70 95 71 96 Table Xb
8. L3 coil 56 81 56 81 Table Xb
9. HS body of Q1 37 62 37 62 Table Xb
10. BT1 body 19 44 18 43 Table Xb
11.V2 body 22 47 20 45 Table Xb
12. upc body 24 49 22 47 Table Xb
13. H.DD body 17 42 14 39 Table Xb
14. F.DD body 13 38 11 36 Table Xb
15. CD rom body 17 42 15 40 Table Xb
16. V3 body 25 50 24 49 Table Xb
17. T2 coil for inverter 57 97 57 97 Cl.B Table Xa
18. T2 core for inverter 54 94 55 95 Cl.B Table Xa
19. F3 coil for inverter 50 75 49 74 Table Xb
20. Surface of PC 10 50 8 48 75 Table Xa
12. SMP for building-in:
Skynet SNP-8086-M. See
Nemko ref. 200039133
Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise for
determination of the final temperature T.
Model PPC-153M-zT
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Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise for
determination of the final temperature T.
Model PPC-120M
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Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise for
determination of the final temperature T.
Model PPC-153M
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Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise for
determination of the final temperature T.
Model PPC-150M
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Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise for
determination of the final temperature T.
Model PPC-120M
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Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise for
determination of the final temperature T.
Model PPC-153M
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42.1 - 42.2 Determination of the temperature rise Not applicable. SMP used N
of copper windings by the resistance
method:
R 2 R1
t = (234 .5 + t 1 ) ( t 2 t 1 )
R1
Equipment:
Initials Tester / Date: /
Comments According to IEC 60601-1 clause 42.1, table Xa and Xb, 400 C or 250 C is added to the temperature rise
for determination of the final temperature T.
43 FIRE PREVENTION
43.1 Strength and rigidity of the equipment The equipment is well constructed with regard to avoid P
are sufficient to avoid fire hazards (see fire hazard.
21)
43.2 Oxygen enriched atmospheres: No general requirement.
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46 HUMAN ERRORS
No general requirement.
47 ELECTROSTATIC DISCHARGES
No general requirement.
48 BIOCOMPATIBILITY
Equipment parts and accessories No parts of the equipment or accessories are intended N
intended to come into contact with to come into contact with biological tissues, cells or body
biological tissues, cells or body fluids fluids.
assessed and documented as given in
ISO 10993-1.
Inspection of information provided by
manufacturer.
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Comments
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Test No Applied single fault condition (refer to 52.5) 1) Observed result (e.g. hazards which arise or not) 2)
from 52.5
See Nemko ref. No. 200039133
53 ENVIRONMENTAL TESTS
See Sub-clause 4.10 and Clause 10.
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56.8 Indicators
Unless indication is otherwise apparent Colours, see Sub-clause 6.7. P
to the operator from normal operating
position , indicator lights are provided:
- to indicate that equipment is See Sub-clause 6.3 a. P
energised
- to indicate the operation of non- Not applicable. N
luminous heaters
- to indicate when output exists if a Not applicable. . N
safety hazard could result
Charging mode is visibly indicated to Not applicable. N
the operator
56.10 Actuating parts of controls
56.10 a Accessible parts of electrical controls No actuating parts N
comply with requirements in Sub-
clause 16 c
56.10 b Fixing, prevention of maladjustments: N
Actuating parts are adequately secured N
to prevent them working loose during
normal use
Controls are secured to prevent N
movement relative to scale marking
Detachable indicating devices are N
prevented from incorrect connection
without the use of a tool
Equipment:
Initia ls Tester / Date: /
Rotating controls Gripping diameter of the Test torque Remarks
knob (mm) (Nm)
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57.9.1 a Short-circuit test(s) at 90 to 110 percent of See Nemko ref. No. 200039133. P
rated supply voltage / voltage range SMP mdoel SNP -8086-M
Supply voltage:
Equipment:
Initials Tester / Date:
Winding under test*) Comments
T1:
pin 8-13,14 Shutdown after 1 sec., cycle protection
pin FL2-10,11,12 Shutdown after 1 sec., cycle protection
pin 10,11,12-FL1 Shutdown after 1 sec., cycle protection
OUTPUT OVERLOAD
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57.9.2 Dielectric strength of electrical insulation The electrical insulation between primary winding
between turns and layers and other windings, screens and the core of the
transformer(s) have been investigated by the tests
performed as described in Clause 20.
Insulation between turns and layers, test Not applicable. SMP used N
performed according to 57.9.2:
Voltage used in test:
Frequency used in test:
57.9.4 Construction
Identification, Manufacturer and type Total Insula- Nominal rated General Protection
reference, rated tion voltages and construction*) devices
marking (e.g. T1, power material currents of the (manufacturer,
T2, etc.) (VA) class windings type and rating,
location)
Mains SKYNET (H.K.) Class B 100-250Vac,
transforme. T1 Electronic Co. Ltd. 3A
360-8086-M
Inverter Sen Huei, TRN-0067 Class B
transformers:
T1, T2
TDK Class B
SRW15/20E M-
T11H004
NIA15/20EM-T11H004 Class B
*) A construction diagram has to be added to this test report for each transformer mentioned above.
Drawing
See Nemko ref. No 200039133
Comments The transformer consists of windings wounded on a bobbin with separate integrated forms. The
barrier between the primary and secondary windings has a split which increase the distance
between them.
Creepage distances and air clearances of See Nemko ref. No 200039133
transformers
Insulation between Ref. Air clearance (mm) Creepage distance (mm) Notes
voltage (V) Required Measured Required Measured
Primary - Primary 250 1,6 2,1 3,0 3,4 Parts other
than windings
Primary - Secondary 250 5,0 11,5 8,0 11,5 Windings
57.9.4 a One of the following methods is used to One bobbin with concentric windings separated by P
separate primary from secondary and patient double or reinforced insulation
connected windings:
57.9.4 c Means are provided to prevent displacement P
of end turns
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supplementary A -b
insulation A -c
A -j
B-d
B-c
Comments
57.10 b Statements , test specifications etc. observed
57.10 d Statements regarding measurement of
creepage distances and clearances observed
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19.4 f APPENDIX 1
Fig. 16 in Measurement of the earth leakage P
IEC 60601-1 current
L(N)
T1 S5 P1
Rseau P3
Mains V 5
N(L) P1
S1
S10 P1
FE
MD PE
S12 P1
(Measuring supply circuit with one side of the supply mains at approximately earth potential (fig. 10)).
Switch positions NC (S1 = 1) SFC (S1 = 0) Additional SFC*
(see Clause 17.a)* (S1 = 1)
Measured (A) Measured (A) Measured (A)
1 2 1 2 1 2
S5 S10 S12 Before After Before After Before After
1 1 1 180 180
1 1 0 380 381
1 0 1 182 182
1 0 0 378 379
0 1 1 184 185
0 1 0 381 382
0 0 1 181 181
0 0 0 381 382
1)Insulation-enclosed
2)Metal enclosed
3)Combination of Insulation- and metal-enclosed 2
and = Before and after humidity preconditioning treatment.
Note: NC = Normal Conditions 1 = Switch Closed * = describe additional SFC according to
SFC = Single Fault Condition 0 = Switch Open Sub-clause 17 a in notes above
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19.4 g APPENDIX 2
Fig. 18 in Measurement of the enclosure FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 leakage current
L(N)
T2 S9
Rseau
Mains
V V2
N(L)
P1
L(N) 1
T1 S5 P1
Rseau P3
Mains V V1 5
N(L) MD2
P1
S1
S10 P1
FE
S7 P1
PE
MD1
P1
S12
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19.4 g APPENDIX 2
Fig. 18 in Measurement of the enclosure FOR INTERNALLY POWERED EQUIPMENT N
IEC 60601-1 leakage current
Normal Condition
Measured (A)
1 2
Before After
Comments :
1 2
and = Before and after humidity preconditioning treatment.
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19.4 h APPENDIX 3
Fig. 20 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT N
IEC 60601-1 current
1
L(N)
T1 P3
S5 P1
Rseau
Mains V 5
N(L) P1
S1
S10 P1
FE
S7 P1
PE
6
P1
MD
S13
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19.4 h APPENDIX 3
Fig. 23 in Measurement of the patient leakage FOR INTERNALLY POWERED EQUIPMENT N
IEC 60601-1 current
Normal Condition
Measured (A)
1 2
Before After
Comments :
1 2
and = Before and after humidity preconditioning treatment.
Page 67 of 73
Nemko ref. no.: 200043138
19.4 h2 APPENDIX 4
Fig. 21 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT N
IEC 60601-1 current with mains voltage on the f-
type isolated (floating) applied part
1 6
L(N)
T1 S5 P1
Rseau P3
Mains V V1 5
N(L) P1
S1
3
S10 P1
FE
S7 P1 3
PE
P1
L(N) MD
T2 S9 R
Rseau
Mains V V2
N(L)
S13
1 1 1
1 1 0
1 0 1
1 0 0
0 1 1
0 1 0
0 0 1
0 0 0
1 2
and = Before and after humidity preconditioning treatment.
Note: S7 not used for Class II equipment NC = Normal Conditions 1 = Switch Closed
SFC = Single Fault Condition 0 = Switch Open
Page 68 of 73
Nemko ref. no.: 200043138
19.4 h2 APPENDIX 4
Fig. 24 in Measurement of the patient leakage FOR INTERNALLY POWERED EQUIPMENT N
IEC 60601-1 current with mains voltage on the f-
type isolated (floating) applied part
Comments :
1 2
and = Before and after humidity preconditioning treatment.
Page 69 of 73
Nemko ref. no.: 200043138
19.4 h3 APPENDIX 5
Fig. 22 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current with mains voltage on a
signal input or signal output part
1 1 1 113 113
1 1 0 113 113
1 0 1
1 0 0
0 1 1 113 113
0 1 0 113 113
0 0 1
0 0 0
1 2
and = Before and after humidity preconditioning treatment.
Note: S7 not used for Class II equipment NC = Normal Conditions 1 = Switch Closed
SFC = Single Fault Condition 0 = Switch Open
Page 70 of 73
Nemko ref. no.: 200043138
19.4 h3 APPENDIX 5
Fig. 25 in Measurement of the patient leakage FOR INTERNALLY POWERED EQUIPMENT N
IEC 60601-1 current with mains voltage on a
signal input or signal output part
Comments :
1 2
and = Before and after humidity preconditioning treatment.
Page 71 of 73
Nemko ref. no.: 200043138
19.4 j APPENDIX 6
Fig. 26 in Measurement of the patient FOR MAINS OPERATED EQUIPMENT N
IEC 60601-1 auxiliary current
1
L(N)
T1 P3
S5 P1
Rseau
Mains V 5 MD
N(L) P1
S1
S10 P1
FE
S7 P1
PE
Page 72 of 73
Nemko ref. no.: 200043138
19.4 j APPENDIX 6
Fig. 27 in Measurement of the patient FOR INTERNALLY POWERED EQUIPMENT N
IEC 60601-1 auxiliary current
Normal Condition
Measured (A)
1 2
Before After
Comments :
1 2
and = Before and after humidity preconditioning treatment.
Page 73 of 73